Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials & methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT0136766.
Bossi, P., Peris, K., Calzavara-Pinton, P., Queirolo, P., Alfieri, S., Palla, M., Rossi, M. T., Spagnolo, F., Tambone, S., Astolfi, C., Ascierto, P. A., Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study, <<FUTURE ONCOLOGY>>, 2020; 16 (16): 1091-1100. [doi:10.2217/fon-2019-0664] [http://hdl.handle.net/10807/168615]
Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study
Peris, Ketty;
2020
Abstract
Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials & methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT0136766.
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